Phase 2 N=102 Treatment

Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer

Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00587431 ↗

Enrolled (actual)

102

Serious AEs

43.1%

Results posted

Aug 2014

Primary outcome: Primary: PSA of <_ 0.05 ng/ml After Radical Prostatectomy or Radiation Therapy and PSA <_ 2.0 ng/ml for Patients With Clinical Metastases Without Prior Definitive Therapy — 9; 14; 13; 12 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: GnRh (Leuprolide) (Drug); Testosterone Gel (Drug); Docetaxel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Memorial Sloan Kettering Cancer Center
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY PSA of <_ 0.05 ng/ml After Radical Prostatectomy or Radiation Therapy and PSA <_ 2.0 ng/ml for Patients With Clinical Metastases Without Prior Definitive Therapy	9; 14; 13; 12; 0; 0	—
SECONDARY The Effects of Testosterone Administration on Docetaxel Pharmacokinetics.	23.9; 23.6	—

Summary

We postulate that multiple apoptototic events are indusce through testosterone depletion and repletion with taxotere given in conjunction with androgen withdrawal.

Eligibility Criteria

Inclusion Criteria

Diagnosis of prostate adenocarcinoma histologically confirmed at MSKCC or SKCCC.
Patient must have a serum testosterone > 180 ng/dl.
Karnofsky performance status (KPS)>\_70%.
Patients must have adequate organ function as defined by the following
laboratory criteria:
WBC >\_ 3500/mm3
ANC >\_1500/mm3
Platelet count >100,000/mm3
Hemoglobin >8.0g/dL
Creatinine \_ grade 3.
Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80.
Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 6 months after completion of the treatment.
Prior chemotherapy
Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, St. Johns's Wort (hypericum perforatum) and ketoconazole is prohibited.

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Data sourced from ClinicalTrials.gov (NCT00587431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.